Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel Assay and Guidance for Use in CDC Qualified Laboratories

Source: Centers for Medicare and Medicaid Services (CMS). Published: 2/6/2020.
This three-page memorandum provides guidance to surveyors in regard to the authorization for emergency use of the Centers for Disease Control and Prevention (CDC) ’s 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel assay. Upon receipt of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel assay and corresponding manufacturer’s instructions (MI), CDC-qualified laboratories will verify assay performance specifications in their laboratory per the manufacturer’s instructions.
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Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - February 6, 2020 Category: International Medicine & Public Health Source Type: news